Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study

NCT06462170 | Recruiting

• 1 other identifier: 20240236-01H
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months. In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours. With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake.

  Participants will get blood drawn at time 0, 30, 60, 90, and 120 minutes. Blood will be sent for glucose, insulin, and C-peptide measurements. The area under the curve (AUC) will be calculated from these measurements. The AUC for insulin and for C-peptide will be representative of the participant's PIPC.

  12 months

Secondary Outcomes (1)

• The impact of participant's self-reported weight gain in the past year (12 months prior to the single study visit) on participant's PIPC.

  12 months

Study Arms (1)

Pancreatic insulin production after drinking meal replacement shake

EXPERIMENTAL

Nutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity.

Dietary Supplement: Boost Original meal replacement shake

Interventions

Boost Original meal replacement shake DIETARY_SUPPLEMENT

One bottle of Boost Original meal replacement shake.

Pancreatic insulin production after drinking meal replacement shake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent provided
• Age \>= 18 years.
• Diagnosed as type 2 diabetes mellitus.
• Not on insulin therapy.

You may not qualify if:

• Diagnosed as another form of diabetes mellitus.
• Allergic to one or more ingredients in Boost meal replacement shake.
• Unable to fast since midnight and attend in person for the morning protocol.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H7W9, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cathy Sun, MD MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Sun, MD MSc

CONTACT

613-738-8333; csun@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 17, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)